Reviewer backs approval of Xarelto in ACS

An FDA reviewer recommended approval of 2.5 mg twice-daily Xarelto rivaroxaban from Johnson & Johnson (NYSE:JNJ) to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS), non-ST-elevation myocardial infarction or unstable angina. However, the reviewer recommended against including a mortality claim on Xarelto's label and said the drug should be contraindicated in patients with a history of stroke or transient ischemic attack. The reviewer also said the label should include a boxed warning for bleeding risk in patients 75 years of age or older and in patients weighing less than 60 kg. The recommendations came in briefing documents released ahead of Wednesday's Cardiovascular and Renal Drugs Advisory Committee meeting to discuss an sNDA for Xarelto.

The documents noted that 2.5 mg twice-daily Xarelto plus standard of care reduces the rate of CV death, non-fatal MI or non-fatal stroke compared to placebo plus standard of care. However, the reviewer said the 2.5 mg dose was only "nominally" significant in reducing all-cause mortality, while a 5 mg twice-daily dose was not effective. The application has Priority Review, with a June 29 PDUFA date. ...